BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IMPLANTABLE PULSE GENERATOR

    MDR report key: 1790627 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01531
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    December 8, 2009
    Report Date
    July 30, 2013
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R,
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 4. EVALUATION: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. IPG PASSED ALL TESTING INCLUDING LEAD PULL-OUT TEST. SET SCREW WAS OUT OF THE CONNECTOR BLOCK. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. ANS HAS LIMITED INFO RELATED TO THE PT¿S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT¿S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT¿S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 4. SEE MFR REPORT 1627487-2010-01532, 1627487-2010-01533 AND 1627487-2010-01534. THE PT RECEIVED THE SYSTEM CONSISTING OF AN IPG, A PADDLE LEAD AND TWO SINGLE EXTENSIONS ON (B)(6)2009. IT WAS REPORTED THAT THE PT LOST STIMULATION. AN X-RAY CONFIRMED THAT THE EXTENSIONS APPEARED TO HAVE PARTIALLY PULLED OUT OF THE IPG HEADERS AND HAD ALSO MIGRATED TO A LOWER POSITION. THE PT'S ENTIRE SYSTEM WAS EXPLANTED AND RETURNED TO THE MFR FOR EVAL. FOLLOW-UP ON THE PT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ADVANCED NEUROMODULATION SYSTEMS 3788 2744438

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention